National Prescription Services Inc. dba HRI Pharmacy
Form 483 issued November 24, 2014 · Warrenville, Illinois
- Inspection
- Nov 12 – Nov 24, 2014
- Investigator
- Russell K. Riley
- Observations
- 5
- Pages
- 2
- FEI number
- 3011082190
In short: On November 24, 2014, FDA issued a Form 483 with 5 observations to National Prescription Services Inc. dba HRI Pharmacy in Warrenville, Illinois (FEI 3011082190) after an inspection that ran Nov 12 – Nov 24, 2014. The investigator was Russell K. Riley. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is no written testing program designed to assess the…
This inspection in context
Russell K. Riley
7 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmNational Prescription Services Inc. dba HRI Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at National Prescription Services Inc. dba HRI Pharmacy?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected National Prescription Services Inc. dba HRI Pharmacy?
Russell K. Riley is named on this Form 483, for the inspection of Nov 12 – Nov 24, 2014. Each investigator has a profile showing what they cite most.
When was National Prescription Services Inc. dba HRI Pharmacy inspected by FDA?
The inspection ran Nov 12 – Nov 24, 2014, and the Form 483 is dated November 24, 2014.
How do I get the full Form 483 for National Prescription Services Inc. dba HRI Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.